A new peer-reviewed study shows that platinum in silicone gel breast
implants could be toxic for women and their babies. The frightening
results found toxic platinum in breast milk, blood, and other bodily
fluids of women with breast implants. The FDA is now deciding whether
to ignore the research, or delay approval of implants until the
government conducts research to confirm or refute the results.

The FDA has asked for public comments, so they need to hear from you!
Meanwhile, the FDA is quoting an industry-funded researcher who
questions the findings and insists that implants are safe, despite
this research to the contrary.

This might be the last opportunity to take a stand and demand that
government scientists do the research necessary before the FDA makes a
decision to approve silicone gel implants. The FDA will review all the
comments that are received through their official process. Although
the comment period doesn’t end until October, the decision to approve
silicone breast implants could happen much sooner. We need to act
quickly!

We are not providing a sample letter, because the FDA will take your
comments more seriously if they are not identical to everyone else’s.
Feel free to cut and paste or use any information from the talking
points below. Anything you do to make your wording unique (but still
sound reasonable) is a plus.

1. Serious safety questions about platinum in
breast implants remain unanswered. More research is needed on the
toxicity of platinum in the bodies of women with
breast implants, and the health effects on those women and the
children they breastfeed. The FDA should not make any
decision on approving silicone breast implants before more research is
conducted and analyzed.

2. If the FDA approves silicone breast implants, many young women
will get them. Studies have found higher than expected levels of
platinum salts in breast milk and urine of women with implants. If
they breast feed, their babies could potentially be permanently
damaged or chronically ill from exposure to toxic platinum salts.

3 . Platinum salts also could be especially dangerous for breast
cancer survivors. Chemotherapy often includes platinum. If a breast
cancer patient decides to get breast implants, she potentially would
already be exposed to platinum, and then get additional exposure from
her implants. Breast cancer patients already are more susceptible than
other patients to implant ruptures and other complications.
Unfortunately, the companies that are seeking FDA approval for
silicone gel breast implants have conducted research on relatively few
breast cancer patients.

4 . So far, the FDA has relied on implant makers and their paid
consultants to examine this essential question. Implant makers and
their consultants claim that the platinum in implants is safe, but
have failed to study the platinum in the bodies of women with
implants, or their breast milk, to determine if it is platinum salt.
Platinum salt is a toxic form of platinum. These questions are too
important to wait until after the FDA makes implants more available.

WHAT WE WANT: FDA should ask a government agency such as the CDC or
the National Institute of Environmental Health Study (NIEHS) to
conduct a study of a large number of women who have had silicone gel
breast implants for at least 10 years. The study should focus on
women with leaking silicone implants, and evaluate the amounts of
platinum salts in their blood, urine, hair, nails, and breast milk.
The women’s sensitivity to platinum should also be studied, as well as
their health. The FDA should not consider approving silicone gel
breast implants until this study is completed.

Background:

Silicone gel breast implants have never been approved by the FDA, but
last summer the FDA announced its plan to approve them if certain
undisclosed conditions could be met. That plan is under scientific
fire, because a new study published in the Journal of Analytical
Chemistry found very high levels of a toxic form of platinum, called
platinum salt, in the blood and breast milk of women with breast
implants.

Concerned consumer groups, including breast cancer support groups,
have requested that the FDA delay approval of silicone breast implants
until there is additional independent research on the health risks of
platinum from silicone breast implants. One consumer group filed a
formal petition to the FDA on this topic. Unfortunately, the FDA has
hunkered down, claiming that there is no evidence that silicone breast
implants expose women to dangerous levels of platinum—without taking
time to conduct additional research to review the latest study.

The lack of research on platinum is one example of the unknown risks
of breast implants, which is why consumer groups have repeatedly
insisted that the FDA require comprehensive long-term studies before
approving these products. Approximately 200,000 women have reported
serious health problems linked to their breast implants.